Canadian approval for Medtronic’s Micra AV pacemaker

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Medtronic Canada has received a Health Canada licence for Micra  AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical connection between the chambers of the heart (the atria and the ventricle) is impaired.

Micra AV is identical in size and shape to the original leadless Micra Transcatheter Pacing System (TPS), but has additional features including internal atrial sensing algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing “AV synchronous” pacing therapy to patients with AV block, Medtronic said in a press release.

“With the licensing of Micra AV, more patients will benefit from a new way to implant pacemakers,” say Blandine Mondésert, cardiac electrophysiologist at the Montreal Heart Institute, and associate professor at Université de Montréal, Montréal, Canada. “The advantages of leadless pacing include a better quality of pacing, fewer complications related to the leads and pacemaker pocket, cosmetic implantation, and atrioventricular synchronization in patients in sinus rhythm. Real-world use of Micra has shown a 63% reduction in major complications compared to traditional transvenous pacemakersi. Especially in older patients, but also in younger ones, it is a game-changer.”

The MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, published in JACC: Clinical Electrophysiology,  evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study assessed the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. Results from the study, presented at the American Heart Association 2019 Scientific Sessions, showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having >70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P<0.001 for proportion of patients with >70% synchrony). The study’s primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing.

“Medtronic remarkably changed healthcare 63 years ago with the first battery powered pacemakers, and we are proud to continue pioneering in the field of pacing by offering the first miniaturised, leadless pacing portfolio,” said Mitch Leschuk, senior director of the Cardiovascular portfolio at Medtronic Canada. “Micra AV reinvents our own innovation, expanding the benefits of leadless pacemakers to more patients.”


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